Massage Therapy in Treating Patients With Cancer Pain

Pain Clinical Trial

Official title:

Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082290
• Other study ID #: 03-046
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2004
• Last updated: December 17, 2015
• Start date: May 2003

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Massage therapy may help lessen pain caused by cancer.

PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.

Description:

OBJECTIVES:

• Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.

• Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

• Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.

• Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.

• Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of cancer

• Baseline pain score = 2 on a 0-10 rating scale where 0 = no pain

• Pain syndrome must be the result of cancer and/or cancer treatment

• No postoperative or other acute procedural pain

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Concurrent pharmacologic pain therapy allowed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• massage therapy

• visit with a volunteer

• period of quiet time

Behavioral:
• questionaire about pain

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in pain	A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain	24 hours after treatment	No